Multimedia Psychoeducation or Print Education in Preparing Cancer Patients for Decision Making About Clinical Trials
2021年1月25日 更新者：Gary Morrow
Evaluation of Psychoeducation for Cancer Patients Eligible for Clinical Trials
This randomized clinical trial compares multimedia psychoeducation to print education in preparing patients with cancer for decision making about clinical trial participation.
Multimedia psychoeducation includes a digital video disc (DVD) and written materials with a combined focus on knowledge and attitude change, and may be an effective method to help patients prepare for decision making about clinical trial participation.
It is not yet known whether a multimedia psychoeducation is more effective than print education in preparing patients for decision making about clinical trials.
調査の概要
詳細な説明
PRIMARY OBJECTIVES:
I. To determine the effect of intervention assignment on patients' preparedness for decision making about clinical trial participation.
SECONDARY OBJECTIVES:
I. To determine the effect of intervention assignment on indicators of the quality of patients' decision making about clinical trial participation.
II. To examine mechanisms by which multimedia psychoeducation (MP) exerts its expected positive effects on preparedness for decision making.
TERTIARY OBJECTIVES:
I. To explore the effects of intervention assignment on clinical trial participation.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the National Cancer Institute (NCI) booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
ARM II: Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a digital video disk (DVD) and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
After completion of study, patients are followed up at 3-7 and 49-56 days.
研究の種類
介入
入学 (実際)
418
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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California
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San Diego、California、アメリカ、92182
- San Diego State University
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-
Florida
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Tampa、Florida、アメリカ、33612
- H. Lee Moffitt Cancer Center and Research Institute
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-
Hawaii
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Honolulu、Hawaii、アメリカ、96813
- Hawaii MU-NCORP
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-
Illinois
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Decatur、Illinois、アメリカ、62526
- Heartland NCORP
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Kansas
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Prairie Village、Kansas、アメリカ、66208
- Kansas City Clinical Oncology Program
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Louisiana
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New Orleans、Louisiana、アメリカ、70112
- Gulf South MU-NCORP
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Michigan
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Grand Rapids、Michigan、アメリカ、49503
- Cancer Research Consortium of West Michigan
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Minnesota
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Minneapolis、Minnesota、アメリカ、55426
- Metro MN NCORP
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Nevada
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Las Vegas、Nevada、アメリカ、89106
- Nevada Cancer Research Foundation NCORP
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Las Vegas、Nevada、アメリカ、89106
- Nevada NCORP
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New York
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Rochester、New York、アメリカ、14642
- URCC / University of Rochester NCORP Research Base
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North Carolina
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Winston-Salem、North Carolina、アメリカ、27104
- Southeast Clinical Oncology Research Consortium
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Ohio
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Columbus、Ohio、アメリカ、43215
- Columbus NCORP
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Dayton、Ohio、アメリカ、45420
- Dayton Community Oncology Program
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Pennsylvania
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Danville、Pennsylvania、アメリカ、17822
- Geisinger Cancer Institute NCORP
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South Carolina
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Greenville、South Carolina、アメリカ、29615
- Greenville Health System Cancer Instutite/Greenville NCORP
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Wisconsin
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Marshfield、Wisconsin、アメリカ、54449
- Wisconsin NCORP
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Milwaukee、Wisconsin、アメリカ、53226
- Aurora NCORP
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
説明
Inclusion Criteria:
- Be able to speak and read English
- Be diagnosed with cancer
- Have been informed of their eligibility for a specific phase II or III therapeutic clinical trial open for enrollment at the participating NCI Community Oncology Research Program (NCORP) site
- Have already met one or more eligibility criteria and have a reasonable expectation of meeting any remaining eligibility criteria for the therapeutic clinical trial
- Be capable of providing written informed consent for study participation
Exclusion Criteria:
- Participants must not have been asked previously to participate in another therapeutic cancer clinical trial
- Participants must not have already made a decision to participate in the phase II or III therapeutic clinical trial for which they were informed of their eligibility
- Participants must not have documented or observable visual, auditory, psychiatric, or neurological disorders that would interfere with study participation (e.g., blindness, deafness, psychosis, or dementia)
- Participants must not be eligible only for phase I trial; these patients are excluded because few of these trials are offered at NCORP sites and because their design and goals differ considerably from those of phase II and III trials
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Arm I (print educational)
Participants undergo a print educational intervention during which they meet with a site coordinator and are instructed to read the NCI booklet titled Taking Part in Cancer Treatment Studies, comprised primarily of information about the nature and conduct of cancer clinical trials.
|
print educational intervention
他の名前：
|
|
実験的：Arm II (multimedia psychoeducational)
Participants undergo a multimedia psychoeducational intervention during which they meet with a site coordinator and are instructed to view a DVD and read a booklet titled Clinical Trials: Are They Right For You? Participants are encouraged to watch the DVD and read the booklet again at home.
|
multimedia psychoeducational intervention
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Preparedness for Decision Making About Clinical Trial Participation, Measured Using Scores From the Preparation for Decision Making Scale
時間枠：Day 3 to 7
|
Preparation for Decision Making Scale (PDMS) is a valid and reliable 10-item self-report measure for which respondents rate the usefulness of materials they were provided in preparing them to communicate with their health care provider and make a health care decision.
Each item is scored 1 to 5 where 1=Not at All, 2=A Little, 3=Somewhat, 4=Quite a Bit, 5=A Great Deal.
Larger number is better.
All 10 scores are summed, then divided by 10; The result - 1 is then multiplied by 25 and we have a range from 0 (less prepared) - 100 (most prepared).
|
Day 3 to 7
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
The Decision Regret Scale (DRS)
時間枠：Day 49-56
|
The Decision Regret Scale (DRS) is a five-item paper and pencil self-report measure that asks subjects to reflect on a particular decision and then rate each item on a Likert scale from 1 (strongly agree) to 5 (strongly disagree).
A mean score for the DRS is calculated by reverse scoring the two negatively phrased items and dividing by five.
The mean scores are converted to a score ranging from 0 to 100 by subtracting 1 and multiplying by 25 and higher scores represent increases in the severity of decision regret.
Higher scores are worse.
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Day 49-56
|
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The Decisional Conflict Scale (DCS)
時間枠：Day 49-56
|
The Decisional Conflict Scale (DCS) is a valid and reliable 16-item self-report measure that assesses the extent to which respondents experience certainty, satisfaction, and confidence following a health care decision.
In the present study, it will be keyed to the decision about therapeutic clinical trial participation.
Instructions given to respondents include asking them to reflect on the decisions have just made or are about to make and to respond to statements in the DCS using a five-point Likert scale.
Responses to each statement are scored from 1 (strongly agree) to 5 (strongly disagree), with negative statements having reverse scoring; thus high scores indicate higher decisional conflict.
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Day 49-56
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
To Explore the Effects of Intervention Assignment on Clinical Trial Participation.
時間枠：Day 49-56
|
Given the ethical perspective that patients have a right to make autonomous decisions about clinical trial participation, no hypothesis is offered about the effect of intervention assignment on clinical trial participation rates.
To conduct the exploratory analysis regarding the effects of intervention assignment on clinical trial participation, data for all patients offered participation in a therapeutic clinical trial will be entered into a 2 (Intervention: MP or PE) x 2 (Clinical Trial Participation: Yes or No/Still Deciding) contingency table and analyzed using either a Fisher exact test or chi-square test as appropriate.
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Day 49-56
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Paul Jacobsen、University of Rochester
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2014年5月1日
一次修了 (実際)
2016年8月31日
研究の完了 (実際)
2016年11月1日
試験登録日
最初に提出
2014年1月31日
QC基準を満たした最初の提出物
2014年1月31日
最初の投稿 (見積もり)
2014年2月4日
学習記録の更新
投稿された最後の更新 (実際)
2021年1月27日
QC基準を満たした最後の更新が送信されました
2021年1月25日
最終確認日
2021年1月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- URCC12107 (その他の識別子：University of Rochester)
- U10CA037420 (米国 NIH グラント/契約)
- NCI-2013-02237 (レジストリ識別子：CTRP (Clinical Trial Reporting Program))
- URCC-12107 (その他の識別子：DCP)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。